Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
interferon alfa
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C, immunologic disorders and infectious disorders, rare disease, viral infection
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative No decompensated cirrhosis --Prior/Concurrent Therapy-- No concurrent immunosuppressives At least 1 year since interferon --Patient Characteristics-- Hepatic: No other cause of liver disease Other: Not HIV positive
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004804
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Tulane University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00004804
Brief Title
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
February 1997
Overall Recruitment Status
Completed
Study Start Date
August 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Tulane University School of Medicine
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.
II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.
Detailed Description
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.
The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.
The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis C, immunologic disorders and infectious disorders, rare disease, viral infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
57 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon alfa
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative
No decompensated cirrhosis
--Prior/Concurrent Therapy--
No concurrent immunosuppressives At least 1 year since interferon
--Patient Characteristics--
Hepatic: No other cause of liver disease
Other: Not HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna S. F. Lok
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
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